Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety of voriconazole as treatment of invasive aspergillosis (fungal infection) and other rare molds in children

Conditions: Invasive Aspergillosis

Summary: the purpose of this study is to evaluate the safety profile of voriconazole (an antifungal drug) when used in children who have invasive aspergillosis (ia) and other rare systemic fungal infections.


Eligibility criteria:
inclusion criteria: * immunocompromised with clinically compatible illness. * diagnosis of proven or probable or possible invasive aspergillosis (based on a modified version of the revised eortc/msg consensus definitions). * diagnosis of infection due to scedosporium or fusarium species. * male and female from 2 to 17 years of age. * females with childbearing potential must have negative pregnancy test and be using appropriate contraception. exclusion criteria: * allergy or hypersensitivity to the azole drugs. * female subjects who are pregnant or lactating. * patients who received more than four days of antifungal drugs to treat the current episode of invasive aspergillosis or rare mold infection. * received within 24 hours prior to enrollment drugs that may cause qt interval prolongation. * significant liver, kidney or heart dysfunction. * not expected to survive for at least 5 days.

Keywords: pediatrics voriconazole invasive fungal infection invasive aspergillosis immunocompromized
the press ra: protein and resistance exercise supplementation study for rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will evaluate if the combination of resistance exercise and protein supplementation will increase muscle strength and muscle mass among older individuals with rheumatoid arthritis (ra).

this study proposes a randomized trial to evaluate a tailored 16-week resistance exercise program, in combination with protein supplementation, for older individuals with ra. the exercise protocol in this study is distinctive because it combines dynamic and isometric (static) resistance exercise performed on specialized equipment that can accommodate the range of motion limitations frequently encountered in the older ra population. this study will also begin to evaluate if additional benefit can be achieved with daily protein supplementation

Eligibility criteria:
inclusion criteria: * age 60-95 years * diagnosis of rheumatoid arthritis * willing to participate in twice weekly exercise sessions exclusion criteria: * cognitive impairment * recent heart surgery (within past 12 months) * severe kidney disease * use of supplemental oxygen * presence of pacemaker * diabetes that requires insulin for management * allergy to soy or milk

Keywords: rheumatoid arthritis
candesartan in the prevention of relapsing atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to test the hypothesis that treatment with the angiotensin ii type 1 receptor antagonist candesartan may reduce the recurrence rate of atrial fibrillation after electrical cardioversion.

background: the most effective procedure to restore sinus rhythm in patients with persistent atrial fibrillation (af) is electrical cardioversion, but af recurs in 60-80% of the patients during the first year. af is associated with electrical and anatomical remodelling of the atria, and angiotensin ii is involved in the remodelling process. studies have indicated that the angiotensin ii type 1 receptor antagonist candesartan may counteract both electrical and anatomical remodelling induced by af. the investigators therefore hypothesised that treatment with candesartan may reduce the recurrence rate of af after electrical cardioversion. study design: 171 patients with persistent af scheduled for electrical cardioversion are randomised in a double blind, placebo-controlled study. the patients receive tablets of candesartan 8 mg or matching placebo once daily for 3-6 weeks before cardioversion, and candesartan 16 mg or matching placebo once daily for 6 months after cardioversion. the study medication is discontinued if electrical cardioversion is unsuccessful or if af recurrence is documented. primary endpoint is recurrence of af. clinical, electrocardiographic, echocardiographic and biochemical markers will be analysed.

Eligibility criteria:
inclusion criteria: * patients with atrial fibrillation, diagnosed electrocardiographically, of more than 48 hours duration in whom direct current (dc) cardioversion is planned. exclusion criteria: * patients with a history of known hypersensitivity or contraindication to any angiotensin ii receptor blocker or any angiotensin-converting enzyme (ace) inhibitor. * patients currently receiving an ace inhibitor or angiotensin ii antagonist because of heart failure or other strong indication. * patients currently receiving any antiarrhythmic medication including sotalol. other beta-blockers will not be regarded as specific antiarrhythmic agents. * significant renal artery stenosis and any medical condition in which administration of a vasodilator is contraindicated; serum creatinine \> 225 micromol/l; or serum potassium \> 5.5 mmol/l; or serum sodium \< 128 mmol/l. * patients with severe hepatic dysfunction. * life-limiting disease or substance abuse which may affect participation. * patients unwilling to participate. * patients who have previously undergone dc cardioversion for atrial fibrillation within the last month. * thyrotoxicosis. * patients with a systolic blood pressure of \< 100 mm hg. * hypertensive patients requiring intensified treatment prior to dc cardioversion. * pregnancy or lactation.

Keywords: atrial fibrillation. cardioversion. recurrence. candesartan.
lal-br/2001: study treatment to low risk all

Conditions: Acute Lymphoblastic Leukemia

Summary: the purpose of this study is increase the efficacy of consolidation (c1) after an intensification phase with high dose of methotrexate, applying analysis of minimal residual disease

remision induction systemic chemotherapy: prednisolone (pdn): * 60 mg/m2 day, i.v. or p.o., days 1 to 27 * 30 mg/m2 day, i.v. or p.o., days 28 to 35 vincristine (vcr): 1,5 mg/m2 i.v., days 8, 15, 22 and 28. daunorubicin (dnr): 30 mg/m2, i.v., days 8 and 15. l-asparaginase (l-asa): 10.000 ui/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25. cyclophosphamide (cfm): 1000 mg/m2, i.v., day 22. intracranial chemotherapy methotrexate (mtx), cytosine (ara-c) and hydrocortisone, days 1 and 22 consolidation treatment (weeks 6 to 14)with intensificación (c-1) * mercaptopurine (mp) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63 * mtx: 3g/m2, i.v., in 24 hours, days 1, 28 and 56. * vp-16: 150 mg/m2 i.v., days 14-15 and 42-43 * ara-c: 1000 mg/m2 i.v., in 3 hours, days 14-15 and 42-43 * intrathecal treatment, days 1, 28 and 56. reinduction-consolidation treatment (r-c) (weeks 15 to 23) dexamethasone (dxm): * 6 mg/m2 day, p.o., days 1-21 * 3 mg/m2 day, p.o. or i.v., days 22-28 vcr: 1,5 mg/m2, i.v., days 1, 8 and 15 dnr: 30 mg/m2, i.v., days 1 and 8 l-asa: 10.000 ui/m2 i.m. or i.v., days 8 and 9, 15 and 16, 22 and 23. cfm 1000 mg/m2 day, i.v., day 22 mercaptopurine (mp) 50 mg/m2, p.o., days 35-42 mtx: 3g/m2, i.v., in 24 hours, day 35. vp-16: 150 mg/m2 i.v., days 49-50 ara-c: 1.000 mg/m2 i.v., in 3 hours, days 49-50 intrathecal treatment days 1 and 35. maintenance treatment (m-1) continuous treatment * mp 50 mg/m2/day, p.o. * mtx 20 mg/m2/week, i.m. reinductions * vcr: 1,5 mg/m2 i.v., day 1. * pdn: 30 mg/m2/day, i.v. or p.o., days 1 to 7 * l-asa: 20.000 ui/m2, i.m. or i.v., day 1. * intrathecal treatment day 1 five cycles, weeks 24, 30, 36, 42 and 48. during the week of administration cycle, continuous chemotherapy should be suspended. intrathecal treatment: at the start of any reinduction cycle maintenance treatment (m-2) (weeks 55-108) * mp 50 mg/m2/day, p.o. * mtx 20 mg/m2/week, i.m. * intrathecal treatment, weeks 54 and 108 at the end of treatment should be done the study of mrd (flux cytometry)

Eligibility criteria:
inclusion criteria: * diagnoses of low risk acute lymphoblastic leukemia in children no treated previously exclusion criteria: * mature b-all (fabl3) or with cytogenetic all "burkitt-like" alterations (t\[8;14\], t\[2;8\], t\[8;22\]) * mixed forms of all * acute leukemia no differentiate * patients with coronary disorders, valvular or hypertensive cardiopathy * patients with chronic liver disorders * chronic pulmonary disorders * renal insufficiency * neurologic disfunctions * ecog 3 and 4 * no signed consent form

Keywords: acute lymphoblastic leukemia minimal residual disease
a phase ii study of stereotactic body radiation therapy in patients with t1n0m0 non-small cell lung cancer (jcog0403)

Conditions: T1N0M0 Non-small Cell Lung Cancer

Summary: to evaluate the efficacy and safety of sbrt for t1n0m0 non-small cell lung cancer

to evaluate the efficacy and safety of sbrt for t1n0m0 non-small cell lung cancer，the following questions should be answered. can srt be an alternative standard treatment modality for inoperable patients? can srt can be a comparable standard treatment modality with lobectomy for operable patients? 12 gy is the daily dose at the isocenter，and 48 gy in total by 4 fractions will be irradiated by stereotactic irradiation over 4 to 8 days.

Eligibility criteria:
inclusion criteria: 1. histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer 2. stage ia with images within 28 days 3. no other intrathoracic lesions 4. dose constraints of the organs at risk seem to be limited within range 5. operable (standard or limited surgery) or inoperable 6. age\>=20 7. no previous thoracic radiation 8. no previous chemotherapy 9. ecog ps=0-2 10. respiratory function (\ =60 torr fev1.0\>=700 ml 11. written informed consent exclusion criteria: 1. no apparent radiation pneumonitis and fibrosis 2. no active tuberculosis without oral drugs 3. no double cancer 4. no pregnancy 5. no psychiatric disorder 6. no steroid administration

Keywords: stereotactic body radiation therapy t1n0m0 non-small cell lung cancer radiotherapy
ultrasonography for nutritional assesment in cirrhotic patients

Conditions: Nutrition Assessment

Summary: ultrasonography of rectus femoris and anterior tibialis muscles for nutritional assesment in cirrhotic patients undergoing major abdominal surgery

in the study, the investigator will use ultrasound to assess the nutritional state of cirrhotic patients after major abdominal surgery,the investigator aim to assess reliability of ultrasound as a bedside,non invasive tool,the investigator will enroll 72 patients for or study which is an observational study

Eligibility criteria:
inclusion criteria: * hepatic patients classified as child a, b undergoing major abdominal surgery (liver resection,whipple,splenectomy,colectomy, common bile duct exploration,by pass surgery) * 18-60 yrs old * no past history of nutritional problems,chronic use of drugs,patients with no orthopedic issues such as skeletal fractures or immobilization exclusion criteria: * refusal of the patient to share in the study, relevant comorbidities (renal, heart disease or copd) * previous immune abnormalities including treatment with corticosteroids * neuromuscular diseases * laparoscopic surgery * patients on parenteral nutrition

Keywords: nutrition,cirrhosis
head to head pilot trial of mailed cologuard to mailed fit

Conditions: Colorectal Cancer

Summary: the objective of this pilot study is to compare the effectiveness of mailed outreach of two stool based tests, cologuard and the fecal immunochemical test (fit) in screening eligible adults ages 45-49 receiving care at the university of california san diego health system.

adults ages 45-49 who are insured, deemed average risk and not currently up to date with colorectal cancer screening will be enrolled. eligible participants will be randomized to either mailed cologuard outreach, facilitated by exact sciences or mailed fit outreach. colorectal cancer screening completion within 3 months will be measured as the primary outcome, in addition to secondary recruitment and intervention-based feasibility outcomes to demonstrate the potential for a larger randomized controlled trial.

Eligibility criteria:
inclusion criteria: * adults ages 45-49 with ehr documentation indicating that the patient has an assigned primary care provider at ucsd health * ≥1 ucsd health system health visit within the last year * resides in san diego or imperial county * currently not up to date with crc screening * insured by private, public or other health insurance. exclusion criteria: * up-to-date with screening * prior history of colonic disease, including inflammatory bowel disease, one or more colorectal neoplastic polyps (i.e., adenomas) or colorectal cancer. * prior history of colectomy * lack of health insurance

Keywords: screening early detection stool blood test
evaluate the safety of gabitril in adults with generalized anxiety disorder

Conditions: General Anxiety Disorder

Summary: to assess the long-term safety and tolerability of tiagabine treatment in patients with generalized anxiety disorder (gad).


Eligibility criteria:
not available at time of registration
evaluation of efficacy and safety of gynomax® xl ovule

Conditions: Trichomonal Vaginitis; Bacterial Vaginosis; Candidal Vulvovaginitis; Mixed Vaginal Infections

Summary: efficacy and safety of gynomax® xl ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections will be evaluated in this open label, single-arm, multicentral study.


Eligibility criteria:
inclusion criteria: * female patients with age ≥ 18 and ≤ 45 years * patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis or mixed infections according to the investigator's decision * signed informed consent exclusion criteria: * known hypersensitivity to active ingredients of the study medications * vaginismus, endometriosis, dyspareunia * detection of urinary tract infection in urinalysis * acute or chronic infections such as pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors * usage of herbal medicines that interfere with microsomal enzymes, especially cytochrome p450 (phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, topiramate, felbamate, griseofulvin, hiv protease inhibitors such as ritonavir, nucleoside reverse transcriptase inhibitors such as efavirenz) * history of cardiovascular event * advanced hypertension and diabetes * presence or known risk or of venous or arterial thromboembolism * undiagnosed abnormal vaginal bleeding, bleeding disorders, genital tumors * use of drugs containing ombitasvir / paritaprevir / ritonavir or dasabuvir during or two weeks before initiation of the study * pregnancy and/or breastfeeding * participation in any other trial 30 days before initiation of the study * postmenopausal women * abuse of alcohol * usage of medications containing acenocoumarol, anisindione, dicoumarol, phenindione, phenprocoumon, warfarin, cholestyramine, cimetidine, cyclosporine, disulfiram, fluorouracil, fosphenitoin, ketoconazole, lithium, rifampin, tacrolimus or propranolol * presence of a sexually transmitted disease such as syphilis, gonorrhea, etc. according to the investigators decision
methylphenidate hydrochloride controlled-release tablets augmentation strategy for patients with obsessive compulsive disorder

Conditions: Obsessive Compulsive Disorder

Summary: explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients with obsessive-compulsive disorder (ocd) receiving fluvoxamine maleate. to test the hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic strategy to improve outcome in ocd.


Eligibility criteria:
inclusion criteria: * informed consent * met dsm-v criteria * y-bocs ≥ 16 * course of illness ≥ 1year * age range between 18\~40 years old * junior high school education level above exclusion criteria: * any other psychiatric axis-i or axis-ii disorders * history of epileptic seizures or any other neurological disorder * any other clinically relevant abnormalities in their medical history or laboratory examinations; alcohol or drug abuser
abdominal electrical stimulation for bowel dysfunction in sci

Conditions: Chronic Spinal Cord Injury

Summary: many people with spinal cord injury (sci) have bowel problems resulting in constipation and need a long time to empty the bowel. some people spend an hour or more to empty their bowel. the investigators want test if using a small device to deliver electrical pulses to the belly (abdomen), would improve bowel function. the investigators hope that electrical stimulation will shorten the time needed to evacuate the bowel (defecation), improve stool consistency, and speed up food passing through the bowel. a pilot study found that electrical stimulation of the belly can speed up defecation if stimulation is making the abdominal muscles contract and squeeze the belly, which is what the investigators expected. however, some results suggested that people may benefit from low stimulation levels without making the muscles contract. therefore, the investigators will do small study at the university of alberta on 12 people who lived with sci for more than 1 year, to find out the best way to apply the electrical stimulation, and to better understand how it works. the participants will use an electrical stimulator at home, to stimulate the skin with 4 sticky pads attached over the abdomen, without causing the muscles to contract. during a 2-month period, they will use the stimulator for 30 minutes before every bowel routine. the investigators will compare how long it takes to empty the bowel, stool consistency, and how long it takes for food to pass through the bowel, with and without using the electrical stimulator.


Eligibility criteria:
inclusion criteria: 1. traumatic or non-traumatic sci 2. \>1 year post injury 3. injury level c2 - s5 (nli, neurological level of injury) 4. ais a, b, c, d (american spinal injury association impairment scale) 5. feels defecation takes too long and wants to do something about it 6. defecation takes \> 30 minutes exclusion criteria: 1. bladder stimulator 2. inflammatory bowel disease 3. pregnancy 4. unable to give consent

Keywords: spinal cord injury functional electrical stimulation transcutaneous electrical stimulation neurogenic bowel dysfunction bowel dysfunction abdominal electrical stimulation sensory stimulation defecation time bowel transit time stool consistency bowel routine
a trial investigating the absolute bioavailability of insulin degludec in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of the trial is to investigate the absolute bioavailability of insulin degludec (ideg) in healthy subjects.


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, vital signs and ecg (electrocardiogram), as judged by the investigator * body mass index 18.0-27.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
comparative bioavailability study of carbidopa/levodopa extended-release tablets under fasting and fed conditions

Conditions: Parkinson Disease

Summary: it is an open-label, balanced, randomized, five-treatment, five-period, five-sequence, multiple oral dose, crossover comparative bioavailability study of different strengths of carbidopa/levodopa extended-release tablets with carbidopa and levodopa tablets in normal, healthy adult human subjects under fasting and fed conditions. the primary objective of the study is to compare the pharmacokinetic profiles between wd-1603 extended-release formulations and carbidopa and levodopa tablets 25mg/100mg following three times a day after oral administration in fasting and fed conditions in healthy subjects and to compare relative bioavailability between treatments.

study wd-1603-1005 is to compare the fluctuation index between wd-1603 extended-release formulations and carbidopa and levodopa tablets following three times a day oral administration and the food effect on the initial absorption of levodopa in the morning in healthy subjects. at least 15 subjects will be enrolled at the beginning of the study and the order of receiving the treatment a, b, c, d \& e for each subject during all the periods of the the study will be determined according to a randomization schedule.

Eligibility criteria:
inclusion criteria: 1. normal, healthy adult human volunteers between 18 to 45 years of age (both inclusive). 2. having a body mass index (bmi) between 18.5 to 29.9 (both inclusive), calculated as weight in kg/ height in m2, a minimum body weight of 50.0 kg. 3. not having any significant disease or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12- lead ecg, and x-ray chest (p/a view) recordings. 4. in the case of female subjects: a. surgically sterilized at least 6 months prior to study participation or if of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra-uterine device during the study and for at least 28 days after the last study drug administration. and b. serum pregnancy test must be negative. exclusion criteria: 1. known hypersensitivity or idiosyncratic reaction to carbidopa or levodopa or any of the excipients or any related drug. 2. history or presence of any disease or condition which might compromise the hemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system. 3. ingestion of a medicine (prescribed \& over the counter (otc) medication including herbal remedies and mao inhibitors) at any time within 30 days before first dosing in period i. in any such case, subject selection will be at the discretion of the principal investigator.

Keywords: wd-1603 carbidopa-levodopa extended-release tablets